BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 20399049 · Received October 8, 2024

    Report

    Report Number
    2955842-2024-19656
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Report Date
    September 11, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE THE MONOPOLAR CURVED SCISSOR INSTRUMENT OR THE TIP COVER ACCESSORY THAT WAS USED DURING THIS REPORTED EVENT; THEREFORE, FAILURE ANALYSIS INVESTIGATIONS COULD NOT BE PERFORMED. LOG REVIEWS COULD NOT BE PERFORMED AS THERE WAS INSUFFICIENT PROCEDURE AND EVENT DATE INFORMATION. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY PROCEDURE, A GAP BETWEEN THE TIP COVER ACCESSORY AND THE SHAFT OF THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT CAUSED A BURN TO MESENTERY TISSUE. AFTER INSTALLING THE TIP COVER ACCESSORY USING THE INSTALLATION TOOL ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, THE ORANGE SURFACE WAS NOT VISIBLE. ELECTROLUBE WAS CONFIRMED AS NOT BEING APPLIED TO THE MCS INSTRUMENT PRIOR TO THE TIP COVER INSTALLATION. THE SETTINGS ON THE THIRD-PARTY GENERATOR WERE 50W FOR CUT AND 50W FOR COAGULATION. WHEN THE BURN INJURY WAS OBSERVED, A PORTION OF THE ORANGE SURFACE ON THE MCS INSTRUMENT WAS VISIBLE. THE BURN CAUSED THE MESENTERIC TISSUE TO CHANGE TO A WHITISH APPEARANCE; HOWEVER, THERE WAS NO CHARRING OR BRUISING. IT IS UNKNOWN IF THE MCS INSTRUMENT TIPS COLLIDED WITH ANY OTHER INSTRUMENT OR IF THE TIPS WERE IN CONTACT WITH THE TISSUE; BUT THE STAFF DID NOT OBSERVE ANY EVIDENCE OF ARCING OF ELECTRICAL ENERGY. THE SURGEON DID NOT PROVIDE ANY MEDICAL TREATMENT NOR DID THE BURNED TISSUE NEED EXCISING. IT IS UNKNOWN IF THERE WAS DAMAGED TO THE TIP COVER ACCESSORY; HOWEVER, THE ISSUE OF THE GAP AND TIP COVER ACCESSORY WAS RESOLVED BY REINSTALLING THE TIP COVER ACCESSORY. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THERE WERE NO POST-OPERATIVE COMPLICATIONS; THE PATIENT HAS SINCE BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53952 DA VINCI TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES